Brussels, 8 November 2010 — As negotiations on an EU-India free trade agreement (FTA) resume in Brussels today, international medical humanitarian organization Médecins Sans Frontières (MSF) is calling on Europe’s highest trade official to halt actions that will dramatically restrict access to affordable generic medicines produced in India.
“European Trade Commissioner Karel De Gucht is attempting to give Europe’s pharmaceutical industry a backdoor to monopolies that lead to high drug prices and will keep pills out of reach of patients,” said Dr. Tido von Schoen-Angerer, Director of MSF’s Campaign for Access to Essential Medicines. “India has a patents law that is strict about what does and what doesn’t deserve a patent, but Europe is using dirty legal tricks to get around this law and block cheaper generic medicines.”
Europe is pushing ‘data exclusivity’ policies that would hamper generic competition for up to ten years. These block the standard practice, recommended by the World Health Organization, of generic makers using existing studies on identical products to get their medicines approved for sale. When India rejected a patent on an AIDS medicine for children, nevirapine syrup, in 2008 for example, it meant generic producers could be certain that they can produce and sell more affordable versions of the syrup.
But if data exclusivity had been in place in India, as the EU now wants, producers would have had to wait up to ten years before selling this drug, even though it did not deserve a patent in the first place.
“Our medical programmes depend on a constant supply of affordable medicines. For people with HIV/AIDS who need medicines to stay alive, a ten-year wait to get a newer drug is not viable. They’ll die waiting,” said Ariane Bauernfeind, Operational Coordinator for MSF projects in South Africa, Malawi, Lesotho and Zimbabwe. “Half of all children born with HIV/AIDS won’t make it to their second birthday without treatment. We can’t let the EU shut down our supply of affordable newer medicines.”
Trade Commissioner Karel De Gucht is also pursuing policies harmful to access to medicines through ACTA, the Anti-Counterfeiting Trade Agreement that has been negotiated in secret. The deal claims to be an effort to protect consumers from fake medicines, but it will inhibit the production of legitimate, affordable and safe medicines by giving companies far reaching powers to block competitors’ products.
“The EU has been far less than truthful in response to our concerns. The devil is in the detail, and we demand Trade Commissioner De Gucht quit the spin that hides the health impact his policies will have for people across the developing world,” said von Schoen-Angerer, as MSF delivered an open letter for the Trade Commissioner. “People whose lives depend on Indian generics have taken to the streets in Delhi, Bangkok, Jakarta and Kathmandu, amplifying the message that EU Trade Commissioner De Gucht needs to back off.”
India has been called the ‘pharmacy of the developing world,’ because it produces affordable versions of medicines that are the cornerstone of treatment programmes everywhere. MSF sources more than 80% of the medicines it uses to treat more than 160,000 people with HIV/AIDS from producers in India, and a recent study in the Journal of the International AIDS Society found that more than 80% of all donor-funded HIV medicine purchases for developing countries from 2003-2008 were for generic drugs from India.
Until 2005, the country did not grant patents on medicines. Since 2005, WTO rules required India to start granting patents on medicines, and already a number of newer HIV drugs are patented, raising serious concerns about their affordability. Fortunately for access to medicines, the Indian patent law reserves patents only for drugs that show a therapeutic benefit over existing ones. But the EU intends to override India’s public health safeguards and the right of the county to balance patents and public health concerns.